RHA® Redensity 940056/01

GUDID 07640173233763

"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233794) is defined as unit of sales and identified with a serial number."

Teoxane SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07640173233763
NIH Device Record Key25b0ba5b-fa47-41ea-b88e-c5d0e3a9a00e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRHA® Redensity
Version Model NumberRHA® Redensity US 1ml Schott/2 aig. Terumo TW30G1/
Catalog Number940056/01
Company DUNS482411860
Company NameTeoxane SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com
Phone877-373-8669
EmailMedical-us@teoxane.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS107640173233763 [Primary]
GS107640173233794 [Package]
Package: Box [2 Units]
In Commercial Distribution

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

On-Brand Devices [RHA® Redensity]

07640173230083"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister con
07640173233763"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister con
07640173234197"One box of RHA® Redensity contains two blisters and one instruction for use. Each blister con
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